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EUROPEAN COMMISSION DG ENTERPRISE and …
EUROPEAN COMMISSION . DG ENTERPRISE and industry . directorate F, Unit F3 Cosmetics and medical devices . MEDICAL DEVICES: Guidance document - Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative MEDDEV 2. 1/3 rev 3. GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES. THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES. Foreword The present Guideline is part of a set of Guidelines relating to questions of application of EC Directives on medical devices.
PARA 1 EUROPEAN COMMISSION DG ENTERPRISE and INDUSTRY Directorate F, Unit F3 “Cosmetics and medical devices” MEDICAL DEVICES: Guidance document Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal
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